A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
1100Conditions
Urothelial Cancer, Bladder Cancer, Genitourinary Cancer, Urogenital Neoplasms, Urogenital CancerSummary
Background:Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.Objective:To learn more about urinary tract cancers.Eligibility:People ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.Design:Participants will be screened with questions about their medical history. Their medical records will be reviewed.Participants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.Participants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.Participants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.Participants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.Some blood and tumor samples may be used for genetic tests.Participants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....
Detailed Description
Background:
* Rare histological variants of the genitourinary (GU) tract include bladder/urachal adenocarcinoma, squamous cell carcinoma, and small cell carcinoma; variants of urothelial carcinoma including plasmacytoid, sarcomatoid; renal tumors including sarcomatoid renal cell carcinoma and renal medullary carcinoma; penile cancers; micropapillary, giant cell, lipid rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns; small cell neuroendocrine carcinoma of the prostate, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe renal cell carcinoma (RCC).
* Some GU tumors occur so infrequently that they are not systematically captured by currently available registries, treatment protocols, or tissue banks. The rarity of these tumors limits the sufficient numbers of patients needed in larger randomized clinical studies to characterize standard treatments or disease course.
* Systematic and longitudinal collection and annotation of clinical history, tissue samples, imaging studies, and other pertinent information in participants with these rare tumors will yield future knowledge and help with the development of subsequent prospective studies to optimize diagnosis and treatment paradigms for less common GU tumors.
Objective:
-Characterization of the natural history of urothelial and rare GU tract malignancies.
Eligibility:
-Participants >= 18 years of age diagnosed with urothelial or rare GU tract malignancies.
Design:
* This will be a long-term multi-center study to comprehensively study participants with rare GU tumors.
* Medical history will be collected, and participants followed throughout the course of their illnesses, with particular attention to patterns of disease presentation, recurrence and progression, response to therapies, and duration of responses.
* Tissue samples and blood will be obtained from participants during this study.
* A broad spectrum of scientific experiments, including genomics and immune monitoring will be performed.
* We anticipate accruing 1000 participants on this protocol.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
- 888-624-1937
Principal Investigator
- Andrea B Apolo, M.D.
Eligibility Criteria
* INCLUSION CRITERIA:
* Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator s discretion.
* Age >18 years.
* Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-Pregnancy
Study Plan
1 / Urothelial cancer
Participants with urothelial cancer.
2 / Rare Bladder or Urinary Tract Histology
Participants with small cell carcinoma, adenocarcinoma, urachal squamous cell carcinoma, or pure sarcomatoid carcinoma. These pure histologies can occur in the bladder and/or urinary tract.
3 / Urothelial Carcinoma Variants
Participants diagnosed with a urothelial variant histologies at any stage.
4 / Rare GU Tumors
Participants with renal medullary carcinoma, testicular Sertoli or Leydig cell tumors, penile cancer, refractory germ cell tumors.
Outcome Measures
Primary Outcome Measures
natural history of urothelial and rare genitourinary cancer
Timeline
Last Updated
November 25, 2024Start Date
June 11, 2021Today
February 5, 2025Completion Date ( Estimated )
December 1, 2042
Sponsors of this trial
Lead Sponsor
National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years